CQV Specialist: Equipment & Validation for Pharma

Echo-Consulting-Group; Manatí (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

ECHO Consulting Group in Manatí, Puerto Rico seeks CQV professionals to support validation activities in regulated pharmaceutical, biotech, or medical device environments. Open to Engineers, Scientists, and Validation Specialists with IQ/OQ/PQ experience and documentation skills.

Responsibilities include protocol development and execution, IQ/OQ/PQ, risk and change control activities, and collaboration across Engineering, Quality, and Manufacturing teams.

Qualifications

• 5+ years of experience in validation, commissioning, qualification, or regulated manufacturing environments.
• Knowledge of cGMP regulations and validation lifecycle.
• Experience supporting IQ/OQ/PQ execution or validation documentation.
• Strong technical writing and documentation skills.

Responsibilities

• Support Commissioning, Qualification, and Validation (CQV) activities.
• Develop, review, and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
• Assist with equipment startup and commissioning activities.
• Author and review validation documentation, including protocols, reports, and discrepancy resolutions.
• Ensure compliance with cGMP regulations, FDA guidelines, and internal quality systems.
• Participate in risk assessments and impact assessments related to validation activities.
• Support change control, deviations, and CAPA investigations when required.
• Collaborate with Engineering, Quality, Laboratory, Manufacturing, and Validation teams.
• Ensure compliance with Good Documentation Practices (GDP) and data integrity principles.

Skills

CQV experience

cGMP knowledge

Technical writing

IQ/OQ/PQ

Education

Bachelor’s degree in Engineering, Chemistry, Microbiology, Biology

Job description

ECHO Consulting Group in Manatí, Puerto Rico seeks CQV professionals to support validation activities in regulated pharmaceutical, biotech, or medical device environments. Open to Engineers, Scientists, and Validation Specialists with IQ/OQ/PQ experience and documentation skills.

Responsibilities include protocol development and execution, IQ/OQ/PQ, risk and change control activities, and collaboration across Engineering, Quality, and Manufacturing teams.